The MediPlus-Foam™ AG, MediPlus-ComfortFoam™ AG, and MediPlus-SuperFoam™ AG Dressings are indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:

Ulcers (venous, arterial, diabetic) .
Pressure Sores ●
. Donor Sites
Surgical Incisions .
Surgical Excisions .
. Burns (1st and 2nd degree)

Device Description

The MediPlus-Foam™ AG Dressings product line is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film and a silver net layer acting as an ... antimicrobial barrier. The product line is available in different sizes. The MediPlus-SuperFoam™ AG Dressings product line has slightly thicker PU foam and is easier to bend for covering wound areas such as elbows or heels.

The MediPlus-ComfortFoam™ AG Dressings is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film coated with acrylic adhesive and extends to act as a border adhesive film to allow application without need for secondary dressing or fixation bandage. The silver net layer acts as an antimicrobial barrier. MediPlus-ComfortFoam AG is useful for body sites where applying a secondary dressing or fixation bandage is not practicable or not desired by the user.

MediPlus-Foam AG, MediPlus-ComfortFoamAG, andMediPlus-SuperEoam AG Dressingsare used as an antimicrobial barrier for partial and full-thickness wounds such as builts, donor sites and graft recipient sites that are judged to be at risk from infection. The product features include: managing moisture level in the wound environment, controlled silver release, and the product mesh facilitates the passage of fluids/exudates through the dressing into the PU foam for adsorption. The dressings can remain on the wound for five to seven (5-7) days dependent on the amount of wound exudates.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "MediPlus-Foam™ AG Dressings," a type of silver-containing wound dressing. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria for AI or diagnostic purposes.

Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria, especially in the context of AI/diagnostic device performance. The document is for a traditional medical device (wound dressing) and its approval is based on equivalence to existing products, supported by biocompatibility and antimicrobial effectiveness testing, not a comparative effectiveness study involving human readers or standalone AI performance.

To directly address your numbered points based only on the provided text, the answer is that this information is Not Applicable or Not Provided for an AI/diagnostic device.

However, I can extract information relevant to the type of device and the regulatory process described:

Device Type: Medical Device (Wound Dressing), specifically Silver Containing Wound Dressing. Product Code: FRO.

Regulatory Pathway: Traditional 510(k), seeking to demonstrate Substantial Equivalence to a predicate device (Smith & Nephew Inc., Allevyn Ag Dressings, 510(k) # K063835).

Here's a breakdown of why each of your requested points cannot be answered from the provided text in the context of AI/diagnostic device performance:

A table of acceptance criteria and the reported device performance: Not Applicable/Provided. This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for an AI or diagnostic device. Performance is framed as demonstrating comparable attributes (technology, materials, intended use) and passing standard tests for biocompatibility and antimicrobial effectiveness for a physical wound dressing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable/Provided. The document refers to "testing requirements of the recognized biocompatibility standard" and "antimicrobial effectiveness" but does not detail the specific sample sizes, data provenance, or study design typical for an AI performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable/Provided. Ground truth establishment by experts is not relevant for the type of testing (biocompatibility, antimicrobial effectiveness) described for this physical medical device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable/Provided. Adjudication methods are not relevant for the testing described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable/Provided. This is a physical wound dressing; it does not involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable/Provided. This is not an algorithm or AI device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not Applicable/Provided. Ground truth as defined for AI/diagnostic studies is not relevant. The "truth" for this device relates to meeting established safety and performance standards for wound dressings (e.g., non-toxic, effectively manages exudate, releases silver as intended).
The sample size for the training set: Not Applicable/Provided. There is no AI training set for this device.
How the ground truth for the training set was established: Not Applicable/Provided. There is no AI training set for this device.

Summary

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K 110062
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SEP - 1 2011

MediPurpose Pte. Ltd. Traditional 510(k) - MediPlus-Foam™ AG Dressings

510(k) Summary

Owner's Information:	MediPurpose, Pte. Ltd.3850 Holcomb Bridge Road, Suite 350Norcross, GA 30092
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.
510(k) Number:
Date Prepared:	December 2010
Trade/Proprietary Name:	MediPlus-Foam™ AG DressingsMediPlus-ComfortFoam™ AG DressingsMediPlus-SuperFoam™ AG Dressings
Common Name:	Silver Containing Wound Dressing
Classification Name:	Dressing, wound, drug
Class:	Unclassified, Pre-Amendment
Product Code:	FRO
Legally MarketedPredicate Devices:	Smith & Nephew Inc., Allevyn Ag Dressings, 510(k) # K063835

Device Description:

. * *

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MediPurpose Pte. Ltd. Traditional 510(k) - MediPlus-Foam™ AG Dressings

K 110062
Page 2 of 2

510(k) Summarv

Intended Use:

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The MediPlus-Foam AG, MediPlus-ComfortFoam AG, and MediPlus-SuperFoam AG Dressings are indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:

Ulcers (venous, arterial, diabetic) .
Pressure Sores ●
. Donor Sites
Surgical Incisions .
Surgical Excisions .
. Burns (1st and 2nd degree)

Similarities and Differences of the Proposed Devices to the Predicate Devices:

Similarities

The MediPlus-Foam AG, MediPlus-ComfortFoam AG, and MediPlus-SuperFoam AG Dressings have the same basic technology characteristics for silver containing wound dressings. The features and benefits of using silver containing wound dressings are the same as the predicate and the indications for use are the same. The materials are comparable in that the silver ions are incorporated in the dressing and the plastics used against the wound bed are proven biocompatible.

Differences

The MediPlus-Foam AG, MediPlus-ComfortFoam AG, and MediPlus-SuperFoam AG Dressings utilize some of the same materials, specifically the use of plastics. The MediPlus-Foam AG, MediPlus-ComfortFoam AG, and MediPlus-SuperFoam AG Dressings comply with testing requirements of the recognized biocompatibility standard (see Section C).

Conclusion:

The MediPlus-Foam AG, MediPlus-ComfortFoam AG, and MediPlus-SuperFoam AG Dressings have the same principles of operation, intended use, and technological characteristics as the predicate device. Testing was completed for biocompatibility and antimicrobial effectiveness and the testing reports are contained in the 510(k) documentation (see Section C).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MediPurpose Pte., Ltd. % Regulatory Resources Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004

3011

Re: K110062

Trade/Device Name: MediPlus-Foam™ AG Dressings MediPlus-ComfortFoam™ AG Dressings MediPlus-SuperFoam™ AG Dressings

Regulatory Class: Unclassified Product Code: FRO Dated: August 01, 2011 Received: August 02, 2011

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a deternination that your device complies with other requirements of the Act

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Page 2 - Ms. Julie Stephens

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cur

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KJ10062 510(k) Number (if known):

Device Name: MediPlus-Foam™ AG Dressings MediPlus-ComfortFoam™ AG Dressings MediPlus-SuperFoam™ AG Dressings

Indications for Use:

Ulcers (venous, arterial, diabetic) .
Pressure Sores
Donor Sites
Surgical Incisions
Surgical Excisions
Burns (1st and 2nd degree)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone keuMKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K110062

Regulation Number and Section

N/A